GALILEO™ LAG SCREW, RIGHT, 10.5mm x 100mm 1099-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00848665015850), received between Aug 29, 2022 and Jun 8, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2024Failure to Advance; Failure to Advance

  ON 05/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN 1192-100 TELESCOPING LAG SCREW, A 1099-110 TELESCOPING LAG SCREW, AND A 1099-100 TELESCOPING LAG SCREW WOULD NOT ADVANCE INTO THE FEMORAL HEAD OF AN AR-9094-10-2030 TROCHANTERIC NAIL. THE TELESCOPING LAG SCREWS WERE USED WITH A NEW TROCHANTERIC NAIL; HOWEVER, THE ISSUE PERSISTED, AND THE TELESCOPING LAG SCREWS WOULD STILL NOT ADVANCE. THE CASE WAS COMPLETED USING A NEW TROCHANTERIC NAIL AND A NEW 1099-110 TELESCOPING LAG SCREW. THE CASE WAS DELAYED ABOUT FIFTEEN MINUTES. THIS WAS DISCOVERED DURING A LEFT HIP IM NAIL PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19494032 ↗
• MalfunctionAug 29, 2022Device Slipped

  ON 6/16/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT ON (B)(6) 2022, A PATIENT UNDERWENT SURGERY FOR A TROCHANTERIC FRACTURE AND AN ARTHREX SHORT TROCHANTERIC NAIL WAS IMPLANTED. TWELVE DAYS POST OPERATIVE, WHILE TRYING TO STAND FROM THE WHEELCHAIR, PATIENT FELT LIKE THE NAIL HAD EXPLODED OUT OF THE LEG. X-RAYS WERE TAKEN OF THE IMPLANTS AND WHILE IT IS STILL UNKNOWN WHAT HAPPENED, IT SEEMS LIKE THE LOCKING RING WAS NOT ABLE TO HOLD THE LAG SCREW IN PLACE. AS OF NOW, THE SURGEON IS NOT PLANNING ON A REVISION SURGERY AND WILL FOLLOW UP AGAIN WITH THE PATIENT IN TWO WEEKS. ADDITIONAL INFORMATION PROVIDED ON 08/08/2022, IT WAS REPORTED THAT ANOTHER 4 WEEK POST OP OCCURRED ON (B)(6) 2022 AND X-RAYS SHOWED THAT THE NAIL HAD FURTHER BACKED OUT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2022, AT THIS TIME THE 1031-200 GALILEO® TROCH NAIL,1099-100 GALILEO LAG SCREW, AND 8001-036 CAPTURED CORTICAL SCREW WERE EXPLANTED. THE SURGEON CONVERTED TO A TOTAL HIP ARTHROPLASTY.

  Patient problems: Implant Pain

  MAUDE report 15310509 ↗